PharmaCM is a clinical trial disclosure platform designed specifically for the regulated environment of Life Sciences. PharmaCM is used to manage the complex process of authoring, reviewing, editing, approving and publishing clinical trial application and disclosure data. Disclosure content is very dynamic. Clinical trial data is constantly being updated, modified and formatted for specific registries such as ClinicalTrials.gov and EudraCT.
The PharmaCM platform helps sponsors manage and track clinical trial disclosure content and processes. A centralized approach to managing disclosure helps global teams working across time zones and creates one authoritative source for all to access.
Sponsor teams can then harmonize information, streamline data entry and maintenance and lower the risk of human errors resulting from manual processes. This level of harmonization means that information can be pulled to support multiple outputs, including public data requests, disclosure on global registries or publishing to a clinical trial sponsor’s website.
Intelligent workflows enable teams to automate review and approval processes while alerts and notifications help to identify and escalate issues before they impact compliance deadlines.
PharmaCM is deployed as a zero-footprint, SaaS-based platform which means reduced infrastructure and support spending and quicker ramp up for disclosure teams.
OPTIONAL BUSINESS MODULES
Optional Business Modules support specific compliance and transparency processes including:
- Clinical Transparency (CT)
- Site Transparency (ST)
- Data Transparency (DT)
- Study Synopsis
- Atlas Compliance Intelligence